NCT01839786

Brief Summary

The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether this non-invasive tool could be used in pulmonary hypertension diagnosis and monitoring.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 21, 2017

Status Verified

April 1, 2013

Enrollment Period

3.7 years

First QC Date

April 18, 2013

Last Update Submit

March 19, 2017

Conditions

Pulmonary Hypertension

Keywords

Pulmonary HypertensionDopplerValsalva

Outcome Measures

Primary Outcomes (1)

  • Find specific features that characterize lung signals of PHTN patients in comparison to control patients

    The outcomes will be elaborate by statistical analysis of whole group data

    18 months

Study Arms (1)

PHTN patients

2\. Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients suspected of PHTN

You may qualify if:

  • Prospective arm:
  • Man or woman aged over 18.
  • With suspicion or diagnosis of pulmonary hypertension.
  • Scheduled to undergo right heart catheterization
  • Able and willing to give informed consent.
  • Retrospective arm:
  • Man or woman aged over 18.
  • With diagnosis of pulmonary hypertension confirmed by right heart catheterization in the past.
  • Able and willing to give informed consent.

You may not qualify if:

  • Both arms:
  • Minor (aged \< 18).
  • People unable or unwilling to give informed consent.
  • Hemodynamically unstable patients.
  • Pregnant women.
  • Prospective arm only:
  • Patients with contra-indication to right heart catheterization.
  • Patients incapable of performing a Valsalva maneuver.
  • Patients with recent myocardial infarction, high degree AV block, severe aortic stenosis or glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center, Pulmonology department

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Issahar Ben-Dov, MD

    Sheba Medical center, Pulmonary institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2013

First Posted

April 25, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

March 21, 2017

Record last verified: 2013-04

Locations

IL(1)